In light of the news surrounding the possibility of implementation of strict measures against Look Alike Sound Alike (LASA) drugs, we are pleased to bring to you this discussion by Aditya Bhargava. Aditya is a third-year law student at NLSIU Bangalore. He is interested in intellectual property, AI regulation and tech law. His previous posts can be accessed here.
Drug Doppelgängers: Unveiling the Dangers of Look-Alike, Sound-Alike (LASA) Medications
By Aditya Bhargava
Imagine a scenario where you walk into a shoe store asking for running sneakers and walk out with basketball shoes. While it might just be a minor inconvenience in the world of footwear, a similar mix-up in the pharmaceutical industry isn’t just inconvenient—it could be life-threatening. This is precisely the problem India faces with look-alike, sound-alike (LASA) drugs. Such mix-ups are more common than one might hope in India’s bustling pharmacies, where ‘Olvance’ might be confused for ‘Oleanz’—one treats hypertension and the other, schizophrenia. (Refer to this for similar examples) The stakes here are clearly higher than wearing basketball shoes for that marathon you planned to run.
In a technical document published in October 2023, the global health authority (WHO) observed that Look-Alike, Sound-Alike (LASA) medications are a well-known source of medication errors. These errors stem from orthographic (look-alike) and phonetic (sound-alike) resemblances between medications, leading to confusion. Such mix-ups can happen between brand-brand, brand-generic, or generic-generic names. These issues were highlighted by Prashant Reddy and Dinesh Thakur in their piece for The Hindu available here. (Published in January 2024). LASA errors can occur at any stage of medication use: prescribing, transcribing or documenting, dispensing, administering and monitoring.
The past six months have been pivotal in this area due to two main developments: (1) the release of a Lancet paper authored by Murali Neelakantan, Parth Sharma, and Ashish Kulkarni, addressing this critical issue, and (2) the proactive engagement of Indian regulatory bodies such as the Drug Technical Advisory Board (DTAB). These recent actions by Indian regulators reflect a determined effort to tighten controls within the pharmaceutical industry, particularly targeting the problems posed by the LASA drugs. This push is motivated by a series of concerning incidents and ongoing advocacy aimed at preventing these hazardous mistakes. While the regulators ponder over the possible regulatory mechanisms, it would be worthwhile to observe the structure and effectiveness of this regulatory framework, as well as its practicality and feasibility. This post will delve into the persistent challenges posed by LASA drugs, recent regulatory responses, judicial interventions, and highlight some of the policy recommendations already available in the literature to mitigate these risks.
The Persistent Challenge of LASA Drugs
Look-alike, sound-alike (LASA) drugs stand out due to its direct impact on patient safety. Imagine ending up consuming ‘Linamac’ (brand name) which is used for both Lenalidomide (treating cancer) and Linagliptin (for diabetes). It definitely sounds scary. According to Neelakantan, Sharma, and Kulkarni the issue is compounded by weak regulatory frameworks, poorly trained pharmacists, and the pervasive problem of drugs being dispensed under similar-sounding or looking brand names without adequate checks. The result has been a marketplace where drugs with vastly different uses often bear confusingly similar names or even identical names.
The problem is particularly acute in a country like India, where the drug market is vast and varied, with medications reaching over 200 countries through the export channels. The country’s drug regulatory framework is overseen by both the Central Drugs Standard Control Organization (CDSCO) and various state authorities, leading to fragmented and sometimes inconsistent application of the law. Historical laxity in drug regulation, as highlighted by incidents of contaminated cough syrups leading to deaths in several countries such as Gambia and Uzbekistan, underscores the global implications of India’s lackadaisical pharmaceutical regulatory practices. In my opinion, these gaps are further exacerbated by India’s linguistic diversity and low English literacy rates, as most drug labels and prescriptions are in English, which only a small fraction of the population can read fluently. The situation is compounded by the packaging of these medicines, which often look similar and use extremely small fonts, making it difficult for the average person to understand the information provided, hence not being able to distinguish between similar sounding medications even if they want to. Furthermore, the likelihood of confusion is so high in certain cases that even trained (forget the badly or even untrained) pharmacists are susceptible to making such goof-ups.
Recent Developments and Regulatory Responses: Moving in the Right Direction?
Earlier in January 2024 (Almost around the same time when Reddy and Thakur’s The Hindu piece was published) , the Drug Technical Advisory Board (DTAB) deliberated on this issue and recommended a prohibition (Read: Should Not be Allowed) on the marketing and manufacturing of different drugs under the same brand name. Following the DTAB’s recommendation, the Director General of Health Services (DGHS) took a proactive step by writing to the Controller General of Patents, Designs, and Trademarks (CGPSD). The aim was to increase surveillance and enforce stricter trademark regulations for pharmaceutical products. This move was in response to persistent concerns about the potential for serious health consequences arising from drug name confusion. It is expected that the Drugs Consultative Committee (DCC) will deliberate and give its recommendations in the matter this month. However, at present there’s nothing concrete.
Irrespective, as mentioned by Reddy and Thakur this is not the first time such concerns have been raised. The Supreme Court of India, as well as various judicial bodies, have historically emphasised the need for stringent controls over drug naming conventions. For example, the Supreme Court of India (in Cadila HealthCare Ltd. vs Cadila Pharmaceuticals Ltd., 2001) and the Parliamentary Standing Committee on Health and Family Welfare in its 59th report (2012) urged the Ministry of Health to put in place processes to prevent the use of names for drugs that are confusingly similar. Despite these judicial nudges, the realignment of regulatory frameworks has been slow without any substantial changes. The letter from the DGHS in May 2024 hence marks a critical step towards actualizing the judicial advisories into actionable policies, which is really what is the need of the hour. But what are some of the possible recommendations that the regulators might want to incorporate while they figure out this menace is something that are mentioned in the subsequent sections.
Judicial Interventions and Their Impact
The judiciary has played a crucial role in shaping the regulatory landscape for LASA drugs. Cases like Cadila Health Care Ltd. v. Cadila Pharmaceuticals Ltd. set significant precedents by advocating for a stricter regime that meticulously evaluates drug names to avoid confusion. However, the enforcement of these directives has been uneven. Recent decisions, such as those involving the trademarks ‘Letroz’ and ‘Letero’, have shown that courts can sometimes rely too heavily on the assumption that prescription mechanisms and the expertise of healthcare professionals are sufficient to mitigate the risks of confusion. This reliance is problematic as it underestimates the potential for human error and overlooks the Supreme Court’s cautions against such assumptions.
Moreover, the role of visual elements in drug identification has become a contentious issue. While trademarks and distinctive packaging play crucial roles in brand identification and consumer loyalty in other industries, their implications in pharmaceuticals are far more consequential. The strong recall value attached to specific colours, shapes, and packaging designs can significantly affect patient compliance and the acceptance of generic equivalents. This was highlighted in the European Court of Justice’s dismissal of GlaxoSmithKline’s claims against Sandoz for using a similar colour scheme on their inhalers—a decision that underscored the need for a balanced approach that considers both trademark rights and public health needs. The same has been argued here by Swaraj and Murali Neelakantan.
One of the most critical yet overlooked aspects of addressing the LASA drug issue is the creation of a centralised database of drug names (See the NHA’s consultation paper on a Drug Registry). Such a database would enable pharmacists, healthcare providers, and regulators to cross-reference drug names efficiently and accurately. The current lack of such a database not only hampers effective regulation but also places an undue burden on healthcare professionals who are on the front lines of dispensing medications.
Policy Recommendations: A Technical Roadmap
To mitigate the risks associated with LASA drugs, a technical and multifaceted approach is required. Some of the following policy recommendations focus on leveraging technology, enhancing regulatory frameworks, and improving educational outreach to address this pressing issue. (More detailed interventions and recommendations are mentioned in the Lancet paper in the form of a table))
- Data Collection: India lacks data on prescription errors, leading the Ministry of Health to equate the absence of data with the absence of a problem. Acknowledging the issue would allow the Ministry to initiate reforms by adopting mechanisms similar to those in the United States and Europe, where drug regulators have dedicated divisions to evaluate drug names on various factors to prevent confusion and reduce prescription errors. Unfortunately, there is a complete lack of political will within the Drug Regulation Section of the Ministry of Health to implement similar reforms in India. (This has been argued by Prashant Reddy T and Dinesh Thakur in their piece above)
- Implementation of Phonetic and Orthographic Analysis Tools: Adopting tools that analyse phonetic and orthographic similarities between drug names during the approval process can significantly reduce the risk of approving LASA drugs. This approach has been successfully implemented by the FDA through its Phonetic and Orthographic Computer Analysis (POCA) tool, which assesses potential drug name confusions before they enter the market. (Recommendation part of the Lancet Study)
- Strengthening Drug Labelling and Packaging Regulations: Clear, distinctive labelling and packaging are crucial in differentiating drugs. Regulations should mandate that drug manufacturers utilise distinct colour schemes, font sizes, and packaging shapes to minimise the risk of LASA errors. This can be supplemented by the use of ‘tall man’ lettering to emphasise differences in drug names that are similar. This means that possible misleading letters are highlighted to avoid confusion (such as HydrOXYzine, an antihistamine, to distinguish it from HydALAzine, an antihypertensive).(Recommendation part of the Lancet Study)
- Enhancing Pharmacovigilance Systems: Developing robust pharmacovigilance systems is essential for monitoring and addressing LASA-related issues post-marketing. These systems should be capable of tracking adverse drug reactions and other safety concerns related to LASA drugs, facilitating swift regulatory action and information dissemination to healthcare providers. (Recommendation part of the Lancet Study)
- Implementing Uniform Color Schemes for Drug Identification: This treats similar conditions or contain the same active ingredients. This approach would not only aid in reducing medication errors but also assist healthcare providers and patients in quickly identifying the correct medication, thereby improving adherence to prescribed treatments. Such colour-coding could be standardised across the industry, with specific colours assigned to distinct drug categories, ensuring that both brand-name and generic drugs adhere to the same colour guidelines. This would mitigate the risks associated with the visual and phonetic similarities of drug names, and potentially streamline the process of drug identification and administration. (This was argued by Swaraj and Murali Neelakantan)
- Regulatory Overhaul and Continuous Training: Regulatory bodies need to enforce stricter controls and regular audits to ensure compliance with drug naming and labelling standards. Continuous professional development and training for pharmacists and healthcare providers on LASA drugs focused on the latest regulatory updates and safety protocols, are crucial in minimising dispensing errors. (Recommendation part of the Lancet Study)
Conclusion
In addition to regulatory and technical solutions, engaging with patients and the community is essential for mitigating LASA risks. Educating patients about the importance of verifying their medications and understanding their prescriptions can empower them to be active participants in their healthcare. Community health programs should focus on improving health literacy, especially in regions with lower educational attainment, to reduce the prevalence of medication errors associated with LASA drugs.
The issue of LASA drugs in India is a glaring example of a systemic problem that requires a multifaceted solution strategy. The recent measures taken by the DGHS and the ongoing deliberations by the Drugs Consultative Committee (DCC) are steps in the right direction but must be part of a larger, sustained effort to reform drug naming and prescription practices. As India moves forward, these reforms must be not only implemented but also rigorously monitored and evaluated to ensure they effectively mitigate the risks associated with LASA drugs. The health of millions depends on the actions taken today, and as such, these efforts must be both robust and relentless.
Apart from the suggestions already mentioned above, readers are encouraged to share their personal experiences with LASA (Look-Alike, Sound-Alike) drugs. Feel free to suggest more strategies through which this menace can be resolved.